(AOF) – Sanofi’s headline (-3.33% to €84.75) closed Thursday’s session at the bottom of the Paris Stock Exchange’s star index. The drug company announced, Tuesday, the suspension of appointment in the clinical trials of the drug tolebrutinib, an experimental treatment for multiple sclerosis (MS). On the same day, UBS lowered its opinion on value from buy to neutral and lowered its price target from €118 to €103. He expects earnings growth to slow in 2023 due to difficulties with amcenestrant, breast cancer treatment, and tolebrutinib.
So Sanofi announced that it was suspending clinical trial placement of tolebrutinib, an experimental treatment for certain forms of multiple sclerosis and myasthenia gravis.
The Food and Drug Administration’s Independent Data Monitoring Committee (iDMC), which is responsible for overseeing clinical trials of toliprotinib, has called for worldwide recruitment of all such trials to be suspended.
At the end of June, the NHS had already requested a partial suspension of trials in the United States after several cases of liver damage associated with the treatment.
As recommended by iDMC, all participants currently receiving tolebrutinib in all studies will continue treatment according to trial protocols, Sanofi said.
The group confirms that it is working closely with the regulatory authorities in order to resume active recruitment during the fourth quarter of 2022.
Sanofi is committed to providing the FDA with the requested information by the end of September 2022.
Also adding the company, the regulatory deadlines for this indicator remain unchanged with submission in recurring MS scheduled for 2024.
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the main points
Global Pharmaceutical Group, created in 1994, first in Europe, and 1
worldwide in vaccines;
– Balanced sales of €37.8 billion from 4 divisions: general medicine for 34%, specialty medicine (immunology, neurology and oncology) for 35%, vaccines for 20%, consumer healthcare;
– the growing share of emerging countries (34% of sales) after the United States (38%) and Europe (28%);
– 4-point business model: streamlined organization, restructured portfolio with more organic products, R&D transformation, strong ambitions in terms of profitability and financial solidity; –
– capital division (excluding L’Oreal: 9.48% of shares and 16.95% of voting rights), Serge Weinberg chairs the 16-member Board of Directors, Paul Hudson is CEO;
A sound balance sheet with net debt down to €8.8 billion and free cash flow of €8.1 billion.
– 2020-2025 “Play to Win” plan aimed at creating an agile group and number two in the world, expressed in two phases: 2020/22: 30% operating margin, €2.5 billion in cost savings / 2023/25: a reduction of 1 / 3 product groups and productivity driven by R&D and digital in factories, operating margin of 32%;
Innovation strategy: 5 research areas: Immunology and Inflammation, Oncology, Neuroscience (particularly Sclerosis), Rare Blood and Rare Diseases, Vaccines / 91 ongoing projects including 29 in phase 3 and 5 awaiting approval by authorities / Developed in collaboration – Kymera for Immunology, Translate Bio in RNA for vaccines – or by acquisition – Kiadis, Biopharma, Kymab for Oncology / Supported by technology platforms: small molecules, antibodies, hemoproteins, genomics;
– Environmental strategy to mobilize the planet, aiming for carbon neutrality of 2030 in 2030, sustainable electricity consumption of 100% vs. 50% in 2021, 100% of sustainable car fleet vs. 22% / in 2027, and elimination of plastic packaging for vaccines / In 2025, all new products/launches of credit lines linked to sustainable development;
The effect of the five “priority” drugs: Amcenestrant (breast cancer), Fitusiran (RNA for hemophilia), Efanesoctocog (hemophilia), Nirsevimab and Nisevimab (respiratory viruses) and Tolebrutinib (multiple sclerosis):
After Origimm, specialists in research in dermatology, Kadmon and Owkin agreed to acquire Amunix in immuno-oncology, further strengthening the research and development suite of biological agents.
– A picture distorted due to the delay in the vaccine against Covid-19;
– IPO of EUROAPI, a group created from the group’s activities in the production of active pharmaceutical ingredients or APIs in Europe, shareholders received 1 share of EUROAPI for 23 shares, the share capital is divided between Sanofi for 30% and BPIrance for 12% ;
2022 target of at least 10% growth in earnings per share;
– 2021 dividend of 3.33 euros.
The inevitable race for new movies
The patent for Merck’s star product, the cancer drug Keytruda, which accounts for more than 35% of its sales, expires in 2028. Despite losing patents since 2019 for its three-star products (Avastin, Herceptine, Rituxan) Roche has been able to renew its portfolio by bringing new molecules to the market. However, the discovery and release of new drugs are increasingly expensive. AstraZeneca spends about $6 billion annually on research and development in the pharmaceutical industry where the patent life is only ten to fifteen years. This leads the laboratories to withdraw from some activities. Thus, J&J, Pfizer, GSK and no doubt Novartis would soon prefer to refocus on specialty drugs and forgo any additional business.